NCT03887715 A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
| NCT ID | NCT03887715 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LivaNova |
| Condition | Treatment Resistant Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,800 participants |
| Start Date | 2019-09-26 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,800 participants in total. It began in 2019-09-26 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.
Eligibility Criteria
Inclusion Criteria: The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode. The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose. The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device. Patients must maintain a stable medication regimen for at least four weeks before device implantation. Exclusion Criteria: Current or lifetime history of psychotic features in any MDE; Current or lifetime history of schizophrenia or schizoaffective disorder; Current or lifetime history of any other psychotic disorder; Current or lifetime history of rapid cycling bipolar disorder; Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder; Current suicidal intent; or Treatment with another investigational device or investigational drugs.
Contact & Investigator
Charles Conway, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT03887715 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03887715 currently recruiting?
Yes, NCT03887715 is actively recruiting participants. Contact the research team at laura.yates@livanova.com for enrollment information.
Where is the NCT03887715 trial being conducted?
This trial is being conducted at Birmingham, United States, Huntsville, United States, Burlingame, United States, Colton, United States and 11 additional locations.
Who is sponsoring the NCT03887715 clinical trial?
NCT03887715 is sponsored by LivaNova. The principal investigator is Charles Conway, MD at Washington University School of Medicine. The trial plans to enroll 6,800 participants.
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